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Clinical Trials/NCT05179629
NCT05179629
Completed
Not Applicable

Effectiveness of M-Tapa Block for Postoperative Analgesia Management in Patients Underwent Laparoscopic Cholesistectomy

Medipol University1 site in 1 country60 target enrollmentJanuary 6, 2022

Overview

Phase
Not Applicable
Intervention
M TAPA block
Conditions
Cholecystitis
Sponsor
Medipol University
Enrollment
60
Locations
1
Primary Endpoint
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

Detailed Description

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. In this study, the investigators aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy surgery.Primary aim is to compare the postoperative pain scores (VAS), and secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Registry
clinicaltrials.gov
Start Date
January 6, 2022
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Principal Investigator

Medipol University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for laparoscopic cholesistectomy surgery under general anesthesia

Exclusion Criteria

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

Arms & Interventions

Group M = M-TAPA group

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 100 mg tramadol will be performed for rescue analgesia.

Intervention: M TAPA block

Outcomes

Primary Outcomes

Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)

Time Frame: Postoperative 24 hours period

Change from Baseline Pain Scores at Postoperative 24 hours.

Secondary Outcomes

  • The need for rescue analgesia(Postoperative 24 hours period)

Study Sites (1)

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